Gabitril

   
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Gabitril


Drug - Gabitril
The trade name of the product as shown on the labeling.

Dosage - TABLET; ORAL
The product dosage form and route separated by a semi-colon.

Active Ingredient(s) - Tiagabine Hydrochloride
Multiple ingredients are in alphabetical order.

Strength - 16MG
The potency of the active ingredient(s), Tiagabine Hydrochloride. May repeat for multiple part products.

Applicant - CEPHALON
The firm name holding legal responsibility for Gabitril. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 020646
The FDA assigned number to Gabitril. Format is nnnnnn.

Product Number - 003
The FDA assigned number to identify Gabitril. Each strength is a separate product. May repeat for multiple part products. Format is nnn.

Therapeutic Equivalence (TE) Code -
The TE Code indicates the therapeutic equivalence rating of generic to innovator Rx products.

Approval Date - Sep 30, 1997
The date Gabitril was approved as stated in the FDA approval letter to the applicant. The format is Mmm dd, yyyy. Products approved prior to the January 1, 1982 contain the phrase: "Approved prior to Jan 1, 1982".

Reference Listed Drug (RLD) - Yes
The pioneer or innovator of Gabitril. The RLD identifies the product Abbreviated New Drug Applications (ANDA) use as a reference. Format is Yes or No.

Type - RX
The group or category of approved drugs Gabitril is in. Format is RX, OTC, DISCN.

Applicant Full Name - Cephalon Inc
The full name of the firm holding legal responsibility for the new application of Gabitril.

Gabitril